MedPath

Varenicline

Generic Name
Varenicline
Brand Names
Champix, Chantix, Tyrvaya
Drug Type
Small Molecule
Chemical Formula
C13H13N3
CAS Number
249296-44-4
Unique Ingredient Identifier
W6HS99O8ZO
Background

Varenicline is a prescription medication used to treat smoking addiction. This medication is the first approved nicotinic receptor partial agonist. Specifically, varenicline is a partial agonist of the alpha4/beta2 subtype of the nicotinic acetylcholine receptor. In addition it acts on alpha3/beta4 and weakly on alpha3beta2 and alpha6-containing receptors. A full agonism was displayed on alpha7-receptors.

On March 9, 2015, the U.S. Food and Drug Administration warned that Varenicline, in the form of Pfizer Inc's quit-smoking drug, Chantix, has been associated with seizures and that some patients who drink while taking the drug may become aggressive or black out. Pfizer is conducting an additional safety study of the drug, results of which are expected in late 2015. The FDA said it is keeping the black box in place at least until the results of the trial are announced.

Indication

For use as an aid in smoking cessation.

Varenicline as a nasal spray is indicated for the symptomatic treatment of dry eye disease.

Associated Conditions
Dry Eye Syndrome (DES)
Associated Therapies
Smoking, Cessation

Crossover Target Engagement Study of Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease (Project #3 - Experiment 3 [UdallP3E3])

Phase 2
Completed
Conditions
Parkinson's Disease
Interventions
Drug: Varenicline
Drug: Placebo
First Posted Date
2020-05-27
Last Posted Date
2021-01-27
Lead Sponsor
University of Michigan
Target Recruit Count
34
Registration Number
NCT04403399
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

Feasibility of Treatment for Vaping Cessation

Early Phase 1
Withdrawn
Conditions
Vaping
Interventions
Drug: Varenicline
Other: brief behavioral therapy
First Posted Date
2020-03-23
Last Posted Date
2023-02-08
Lead Sponsor
Mayo Clinic
Registration Number
NCT04317300

A Novel Human Lab Model for Screening AUD Medications

Phase 2
Completed
Conditions
Alcohol Use Disorder
Interventions
First Posted Date
2020-01-31
Last Posted Date
2023-09-14
Lead Sponsor
University of California, Los Angeles
Target Recruit Count
53
Registration Number
NCT04249882
Locations
🇺🇸

UCLA Addictions Lab, Los Angeles, California, United States

Cannabis and Tobacco Co-use Study

Phase 4
Active, not recruiting
Conditions
Tobacco Use Disorder
Interventions
Drug: Varenicline
Behavioral: Contingency Management
Behavioral: Counseling
First Posted Date
2020-01-14
Last Posted Date
2024-08-01
Lead Sponsor
Medical University of South Carolina
Target Recruit Count
208
Registration Number
NCT04228965
Locations
🇺🇸

Behavioral Health Services of Pickens County, Pickens, South Carolina, United States

🇺🇸

Medical University of South Carolina - Charleston, Charleston, South Carolina, United States

🇺🇸

Medical University of South Carolina - Florence, Florence, South Carolina, United States

Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction

Phase 2
Completed
Conditions
Smoking Cessation
Harm Reduction
Interventions
Drug: Varenicline
Other: e-cigarette
First Posted Date
2019-12-24
Last Posted Date
2022-02-24
Lead Sponsor
Rose Research Center, LLC
Target Recruit Count
25
Registration Number
NCT04210180
Locations
🇺🇸

Rose Research Center, Raleigh, North Carolina, United States

Combining Varenicline and Guanfacine for Smoking Cessation

Phase 2
Recruiting
Conditions
Smoking Cessation
Interventions
First Posted Date
2019-12-13
Last Posted Date
2024-08-12
Lead Sponsor
Yale University
Target Recruit Count
140
Registration Number
NCT04198116
Locations
🇺🇸

Yale University, New Haven, Connecticut, United States

Health Systems Reach Interventions Project

Phase 4
Active, not recruiting
Conditions
Smoking Cessation
Smoking, Cigarette
Interventions
Behavioral: Monetary incentives for initiating treatment
Drug: Varenicline
Drug: Combination nicotine patch and nicotine mini-lozenge treatment
Other: Wisconsin Tobacco Quit Line referral
Behavioral: Automated tailored outreach
Behavioral: Care management
Behavioral: Untailored outreach
Other: Primary care provider referral
Behavioral: Multiple smoking cessation coaching calls
First Posted Date
2019-12-13
Last Posted Date
2024-07-31
Lead Sponsor
University of Wisconsin, Madison
Target Recruit Count
216
Registration Number
NCT04199117
Locations
🇺🇸

UW Center for Tobacco Research and Intervention, Madison, Wisconsin, United States

Mobile Health Interventions for Medication Adherence Among PLWH

Phase 4
Withdrawn
Conditions
HIV/AIDS
Smoking
Smoking Cessation
HIV
Interventions
Drug: Varenicline
Device: Mobile phone application
Behavioral: Contingency management
First Posted Date
2019-12-09
Last Posted Date
2021-09-05
Lead Sponsor
Duke University
Registration Number
NCT04191278

Optimizing Tobacco Use Treatment for PLWHA

Phase 3
Recruiting
Conditions
HIV/AIDS
Nicotine Dependence
Interventions
Drug: Varenicline
Behavioral: Standard treatment
Drug: Nicotine patch
Behavioral: Standard treatment + Managed Problem Solving (MAPS) adherence intervention
First Posted Date
2019-11-25
Last Posted Date
2024-12-06
Lead Sponsor
University of Pennsylvania
Target Recruit Count
340
Registration Number
NCT04176172
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

Mobile Evidence-Based Smoking Cessation for Veterans Living With HIV (MESH)

Phase 4
Completed
Conditions
Smoking
Human Immunodeficiency Virus
Interventions
Drug: Bupropion
Drug: Varenicline
Behavioral: Cognitive Behavioral Therapy
Drug: Nicotine Replacement Therapy
Behavioral: Relapse Prevention Text Messaging
First Posted Date
2019-10-23
Last Posted Date
2023-07-27
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
12
Registration Number
NCT04135937
Locations
🇺🇸

Durham VA Medical Center, Durham, NC, Durham, North Carolina, United States

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